Expanded Access trials sponsored by us, in partnership with manufacturers
A source of real world treatment outcomes data in your targeted population(s)
Experts in site feasibility and full cost recovery
A complete solution to the increasing expectations of wider engagement and access
Expanded Access programs are “Treatment-Use” clinical trials for patients who cannot take part in research trials for the particular therapeutic or diagnostic in serious unsolved disease areas. We take over the burden of sponsoring and managing these programs, because (a) we have specialist knowledge and experience, and (b) manufacturers must spend their resources on the controlled studies required for marketing approval.
Group-level Expanded Access clinical trials (not to be confused with single-patient “compassionate use”) allow meaningful numbers of patients and their physicians to explore a new investigational treatment with a well designed protocol and supply-chain to work in harmony with the continued clinical development of the particular treatment.
When integrated into the drug development cycle, Expanded Access trials bring many benefits to the drug company, including wider patient engagement, increased chances of discovering response-predictive biomarkers, and information that leads to more-highly targeted pivotal trials in historically difficult diseases.
WideTrial sponsors both large group and small to medium sized group EAPs. The allowable size and timing of the program depends on many factors, including the degree of medical need, the safety profile of the product, and the quality of existing clinical data. We have seen every kind of case in the 30 year history of U.S. Expanded Access. We’ll devise the right access strategy for your product.
Jon Katz, MD
Alison Bateman-House, PhD
WideTrial is a third-party sponsor of group-level Expanded Access programs (EAPs). The primary objective of any EAP is to provide pre-approval treatment options in situations of unmet medical need. For us, the secondary objective is to generate clinical data from a larger and more representative set of patients within the target indication. Many patients do not meet the enrollment criteria of traditional research trials, and bringing them into the drug development process can be a win for all parties.
Jess Rabourn is the founder and CEO of WideTrial, the culmination of several projects aimed at improving the treatment landscape for unsolved serious diseases. Since 2010 he has been a nationally recognized speaker on pre-approval access and the economics of breakthrough clinical development. He is executive producer of the Expanded Access Summit., the annual forum on integrating well-designed Expanded Access trials into the modern drug development process. Through his consulting firm, Jess has guided several pharmaceutical companies and disease organizations on regulation and strategy in this area. He is a member of the American Academy of Neurology and was lead author of the Expanded Access section of the submitted draft for FDA's Guidance on ALS Drug Development. Prior to his life sciences career, Jess spent 15 years in the investment management industry at firms in San Francisco and New York. He earned the Chartered Financial Analyst designation in 2004.
Jens Francis is the Chief Technology Officer of WideTrial. He is the founder and Managing Partner of The Faultline Group & Faultline Labs as well as the Founder Emeritus and former Chief Investment Officer of angelMD and the Catalyst Fund where he oversaw a portfolio of 30 medical device, biopharma and digital health companies. Jens is a lifelong technologist with over 25 years in Silicon Valley working closely with entrepreneurial programs at Stanford University and UCSF. He has extensive experience in venture capital and private equity building companies in healthcare, energy and education. Mr. Francis sits on the Boards of numerous companies and non-profits as a technology and business advisor and holds dual degrees in mathematics and computer science from the University of Alaska. He is also the co-recipient of the first Baldrige Award granted in Education through his work with the Bill and Melinda Gates Foundation.
Dr. Jonathan Rubine is the Safety and Medical Director for WideTrial. Dr. Rubine has been involved in the clinical development and market entrance of several novel therapeutics, particularly in neurodegenerative diseases. For more than 15 years, he developed clinical research safety programs for CROs and small-to-medium-sized biopharmaceutical companies. Most recently his work has focused on bringing investigational product to broader ranges of patients through expanded access programs. Dr. Rubine received his MD from Sint Eustatius School of Medicine and MS degree from Florida Atlantic University..